Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

All Drugs and Chemicals

Anti-Infective Agents

Micronutrients

Antineoplastic Agents

Antibodies

Immunoglobulins

Carbamide Peroxide

Iodine

Cadexomer iodine

Tositumomab I-131

Immunologic Factors

Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.

Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab

GSK Clinical Trials

Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.

Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies

Multicenter, Phase II Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

The dosimetry methods were validated for seven different clinical research sites.

Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant's mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001-149999 cells/millimeter cubed (mm\^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.

Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).

Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).

The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.

The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.

Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.

Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.

Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.

Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.

Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.

GlaxoSmithKline

Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.

TST and Iodine I 131 TST

Age, Continuous

Gender

White

Asian

Black

Race/Ethnicity, Customized

GSK Response Center

Clinical site 003

Clinical site 004

Clinical site 005

Clinical site 006

Clinical site 007

Clinical site 008

Clinical site 009

Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose.

Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites

0 cGy

53 cGy

65 cGy

75 cGy

Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)

ITT Exposed Population. Only those participants evaluable for response were analyzed.

Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator

ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.

Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator

Number of Participants With CR and CCR, as Assessed by the Investigator

ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed.

Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator

ITT Exposed Population. Only those participants with a confirmed response were analyzed.

Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator

Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator

ITT Exposed Population. Only those participants with a confirmed CR were analyzed.

Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator

Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator

ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.

Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator

Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator

Median Time to Treatment Failure for All Participants

ITT Exposed Population. Only those participants who died during the study were analyzed.

Overall Survival

ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed.

Time to Disease Progression or Death for Responders, as Assessed by the Investigator

ITT Exposed Population. Only participants with disease progression or those who died were analyzed.

Spots Global Cancer Trial Database for Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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